December 27, 2011
OSCEOLA, Wis.FDA has reported its inspection of NeuroScience Inc.'s facility has uncovered product labeling that renders the products misbranded relative to the Federal Food, Drug, and Cosmetic Act, as well as Title 21 of the Code of Federal Regulations (21 CFR). The agency sent a warning letter to the company Dec. 19, detailing the violations.
Specifically, the products Zymenta and Cerelistwhich contain nutrients such as lipoic acid, acetyl L-carnitine, a-GPC and cholinewere deemed false or misleading because they are labeled and marketed as medical foods but do not meet the statutory definition of a medical food, according to FDA. Specifically, the labeling and website featured claims representing the products as medical foods for the nutritional management of certain metabolic processes associated with dementias of mild-to-moderate Alzheimers disease or mild cognitive impairment.
FDA also took issue with statements about the products' acetyl-L-carnitine provides an acetyl group which is a precursor for acetylcholine synthesis. "While this statement is accurate, we note that an individual does not have to consume certain foods to enable acetylcholine synthesis," FDA wrote. "Acetylcholine can only be synthesized by the enzyme choline acetyltransferase, which is available endogenously from the compounds choline and acetyl-CoA."
Also, the agency noted the NeuroScience products Avipaxin, Calm-PRT, Cerelist, DL-phenylalanine, GI Reset, NorLox, Recolonize-1: Th1 Inhibitor, Taurine, and Zymenta products are promoted for conditions that cause them to be drugs. Specific violative claims include: regulation of pro-inflammatory cytokines (Avipaxin); indicted for high blood pressure (Calm-PRT and Taurine); indicated for mild pain (DL-phenylalanine); reduces pro-inflammatory cytokines(GI-Reset and Recolonize-1); indicated for pain and swelling (NorLox); and inhibiting mild cognitive impairment and Alzheimer's disease (Zymenta and Cerelist).
FDA added this list of products is misbranded because they are offered for conditions that are not "amenable to self-diagnosis and treatment by individuals who are not medical practitioners," which means adequate directions cannot be written so that a layman can use the products safely for their intended uses.
FDA warned the company failure to promptly correct violations may result in regulatory action such as seizure and/or injunction.
You May Also Like
CRN petition to FTC: RCTs aren’t required to substantiate ‘health-benefit’ claimsSep 22, 2023
Collagen peptide ingredient solutions for seniors’ changing needs – infographicSep 19, 2023
Radicle Insights—Covid Eris and dietary supplements: separating fact from fictionSep 21, 2023
More bioavailable hyaluronic acid complex for today’s beauty-from-within consumer – snapshotSep 18, 2023